EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared May 2017

Total Reports

1,616

Reports (30d)

101

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Death Following Tricuspid Surgery Post-ImplantEmerging

registry, implant sapien, sapien ultra, ultra resilia, ultra

reports

Balloon Rupture During Valve-in-Valve Procedure

ultra, clinical specialist, specialist, sapien ultra, resilia valve

reports

Valve Explantation After Long-Term Implant

implant patient, aortic position, registry, sapien ultra, explanted

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

ChangepointcriticalVolume spikehigh

Evidence

Related research

Simulation of left ventricular outflow tract (LVOT) obstruction in transcatheter mitral valve-in-ring replacement

Salvatore Pasta, et al. · Medical Engineering & Physics · 2020

Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes

Miho Fukui, et al. · Circulation · 2022

Durability of transcatheter aortic valve implantation

Julien Ternacle, et al. · EuroIntervention · 2024

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.